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Regulatory strategy (first time right), regulatory compliance and life cycle management are of vital importance to a successful business. Michor Consulting is a young and growing consulting
company working in the area of regulatory affairs, quality assurance, compliance, and business strategy and post market maintenance.
For our offices in Vienna, Austria, we are looking for a
Regulatory Affairs Consultant (m/f/d)
40 hrs /20 hrs
- Dealing with and responding to routine regulatory queries for information and documents in a timely, priority driven manner.
- Prepare, compile, review and/or submit regulatory documentation to regulatory authorities and Notified bodies.
- Write Module 3 documents – CMC
- Experienced in drafting/reviewing INDs/IMPDs for biopharmaceuticals
- Handle licensing and post licensing procedures on behalf of clients including clinical Trial Applications, National, Mutual Recognition and Centralized Applications, medical device CE marking and food supplement notifications.
- Complete International product registrations and export certifications as requested by clients and international regulatory agencies in the EU and in third countries.
- Dossier and development gap analysis (drugs, food supplements) maintain current technical files and declarations of conformity in accordance with the Medical Device Directives.
- Respond to customer queries and questionnaires for regulatory information.
Experience, skills and education:
- Master’s degree (PhD preferred) in a relevant subject: Biotechnology, chemistry, biology or a similar background.
- 3-5 years experience in a similar position.
- Computer proficiency and adaptability working with a variety of databases, word processing, spreadsheet, etc.
- Experience with vaccines and biotech products
- Ability to create effective reports and analysis and communicate them in a timely and effective manner.
- Ability to work in a team environment with shifting priorities and requirements.
- Experience with writing module 3 documents, CMC
- Ability and willingness to learn legal aspects of drug, medical device and food registrations.
- Proficient in English and German.
- Willingness to work at client sites in Europe.
Your salary will be based on experience but will meet the legal requirements according to the Austrian laws and regulations.
To apply for this position please send your letter of motivation and your CV to email@example.com
For further questions please do not hesitate to send us an e-mail
or call us: + 43 (0)699 195 216 62
We are looking forward to meeting you!
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